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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028257
Receipt No. R000027803
Scientific Title A study of the clinical utility of cerebral and somatic mixed blood oxygen saturation measurement using a noninvasive monitor of mixed blood oxygen saturation (INVOS) during pediatric congenital heart surgery.
Date of disclosure of the study information 2017/07/18
Last modified on 2019/07/29

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Basic information
Public title A study of the clinical utility of cerebral and somatic mixed blood oxygen saturation measurement using a noninvasive monitor of mixed blood oxygen saturation (INVOS) during pediatric congenital heart surgery.
Acronym A study of the clinical utility of cerebral and somatic INVOS during pediatric congenital heart surgery.
Scientific Title A study of the clinical utility of cerebral and somatic mixed blood oxygen saturation measurement using a noninvasive monitor of mixed blood oxygen saturation (INVOS) during pediatric congenital heart surgery.
Scientific Title:Acronym A study of the clinical utility of cerebral and somatic INVOS during pediatric congenital heart surgery.
Region
Japan

Condition
Condition congenital heart disease
Classification by specialty
Pediatrics Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate perioperative changes on c-rSO2 and s-rSO2 during pediatric congenital heart surgery, and examine 1) how they relate to circulatory / respiratory dynamics changes at the perioperative period, and 2) how they relate to postoperative prognosis including complications.
Basic objectives2 Others
Basic objectives -Others Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between c-rSO2 and s-rSO2 over time and perioperative circulation / respiratory dynamics

Observational items:Blood pressure, central venous pressure, central venous oxygen saturation, oxygen partial pressure, partial pressure of carbon dioxide, and pH, etc.
Key secondary outcomes Relationship between c-rSO2 and s-rSO2 over time and postoperative prognosis

Observational items:postoperative low output state(LOS), acute kidney injury(AKI), postoperative intubation time, ICU stay duration, complications within one month after operation, and life prognosis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria body weight less than 10 kg
Key exclusion criteria 1. Patients who have other organ complications
2. Patients who have been judged inappropriate by principal investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Morimoto
Organization Hokkaido University Hospital
Division name Department of Anesthesiology
Zip code 060-8648
Address Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
TEL +81-11-706-5732
Email morim2@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Toshihiro
Middle name
Last name Mori
Organization Hokkaido University Hospital
Division name Department of Anesthesiology
Zip code 060-8648
Address Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
TEL +81-11-706-5732
Homepage URL
Email moritoc0114@gmail.com

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital Clinical research and Medical Innovation Center
Address Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
Tel +81-11-706-5732
Email crjimu@huhp.hokudai.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observational study

Management information
Registered date
2017 Year 07 Month 17 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027803

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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